Trial In General Practice Research Articles

Future Health Today: A pragmatic cluster randomised trial of quality improvement activities in general practice for patients at risk of undiagnosed cancer.

Pragmatic, cluster randomised trial in Australian general practice. Practices were randomly assigned to receive recommendations for follow-up investigations for cancer (FHT cancer module) or the active control. Algorithms were applied to the electronic medical record and used demographic information and abnormal test results that are associated with risk of undiagnosed cancer (anaemia/iron-deficiency, thrombocytosis and raised PSA) to identify patients requiring further investigation and provide recommendations for care. The intervention consisted of the FHT cancer module, a case-based learning series and ongoing practice support. Using intention-to-treat approach, between arms difference in the proportion of patients with abnormal test results followed-up according to guidelines was determined at 12-months. 7555 patients were identified as at risk of undiagnosed cancer. At 12-months post-randomisation, 76.2% of patients in the intervention arm had received recommended follow-up (21 practices, n=2820/3709), compared to 70% in the control arm (19 practices, n=2693/3846; estimated between arm difference in percentages=2.6%, 95% CI -2.8% to 7.9%; odds ratio=1.15, 95% CI 0.87-1.53; p=0.332). The FHT cancer module intervention did not increase the proportion of patients receiving guideline-concordant care. The proportion of patients receiving recommended followed-up was high, suggesting a possible ceiling effect for the intervention.

Exploring participants’ characteristics and self-assessed readiness to conduct clinical trials in general practice – baseline analysis of the RaPHaeL practice-based research network

Background Primary care is integral to healthcare systems extending beyond traditional illness management to include preventive care, chronic disease management, and health promotion. Practice-based research networks (PBRNs) have emerged as essential infrastructures for conducting clinical research in primary care. This study explores the establishment of the ‘Research-Practices Halle-Leipzig’ (RaPHaeL) PBRN in Germany, evaluating the characteristics and research readiness of participating practices. Methods A cross-sectional survey (MORNING II) was conducted among all general practitioners (GPs) joining the RaPHaeL PBRN, assessing socio-demographic characteristics, practice infrastructure, and research readiness. After a descriptive analysis, we compared data with a previous study (MORNING) to examine potential differences between PBRN participants and non-participants. We developed a research readiness score (RRS) to quantify practices’ ability to perform clinical research subtasks. Results The response rate was 97.1% and our participants were often male, involved in undergraduate education, generally interested in research or had previous research experiences. However, they differed widely in age and size, staff structure, and patient demographics of their practices. Initially, around two-thirds of the practices were not sufficiently prepared to conduct clinical trials (self-assessed feasibility of relevant subtasks). If further research and documentation tasks are required, patient recruitment estimations are lower than for patient identification and information. Conclusion This study highlights the variability in research readiness among GP practices and shows the need for targeted training. By systematically assessing and enhancing research capabilities of participating GPs, PBRNs can facilitate high-quality clinical research in primary care to improve patient outcomes and healthcare delivery.

Implementation of a tailored multifaceted antibiotic stewardship intervention to improve antibiotic prescribing for urinary tract infections in frail older adults (ImpresU) in four European countries: a process evaluation alongside a pragmatic cluster randomized controlled trial

BackgroundWe previously performed a pragmatic cluster randomized controlled trial (RCT) in general practices and older adult care organizations in Poland, the Netherlands, Norway, and Sweden. We found that a multifaceted antibiotic stewardship intervention (ASI) substantially reduced antibiotic use for suspected urinary tract infections (UTIs) in frail older adults compared with usual care. We aimed to evaluate the implementation process of the ASI to provide recommendations for clinical practice.MethodsWe conducted a process evaluation alongside the cluster RCT. The ASI consisted of a decision-tool and a toolbox, which were implemented using a participatory-action-research (PAR) approach with sessions for education and evaluation. We documented the implementation process of the intervention and administered a questionnaire to health care professionals (HCPs) from participating organizations in the intervention and usual care clusters. We evaluated the multiple components of the intervention and its implementation following a structured framework.ResultsThe questionnaire was completed by 254 HCPs from the 38 participating clusters. All components were largely delivered according to plan and evaluated as useful. The decision-tool and toolbox materials were reported to facilitate decision-making on UTIs. Regarding the PAR approach, educational sessions focusing on the distinction between UTIs and asymptomatic bacteriuria were held in all 19 intervention clusters. In 17 out of these 19 clusters, evaluation sessions took place, which were reported to help remind HCPs to implement the ASI. During both sessions, HCPs valued the reflection that took place and the resulting awareness of their behavior. It allowed them to explore implementation barriers and to tailor their local implementation process to overcome these. For example, HCPs organized extra educational sessions or revised local policies to incorporate the use of the decision-tool. Various HCPs took key roles in implementation. Staff changes and the COVID-19 pandemic were important contextual barriers.ConclusionsWe found each component of the multifaceted ASI and its implementation to have added value in the process to improve antibiotic prescribing for suspected UTIs in a heterogeneous older adult care setting. We recommend using a multifaceted, multidisciplinary approach that enables HCPs to reflect on their current practice and accordingly tailor local implementation.Trial registrationClinicalTrials.gov NCT03970356. Registered on May 31, 2019.

A patient-centred care model for patients with complicated multimorbidity: Protocol for a pilot cluster randomised trial in general practice, municipalities, and hospitals.

Current care is inadequate for patients with complicated multimorbidity, and frequently results in fragmented care. There is no widely agreed-upon optimal organisation of healthcare services for this patient group. By drawing upon existing literature and prior studies, we developed a patient-centred complex intervention for multimorbidity (CIM) and subsequently refined it into CIM version 2 (CIM2). This paper describes the study protocol for a pilot cluster randomised control trail (RCT) evaluating the effectiveness of a general practice-based intervention. CIM2 aims to support integrated care for patients with complicated multimorbidity. CIM2 comprises five elements: 1) Training healthcare professionals, 2) an extended overview consultation in general practice, 3) a nurse care coordinator in general practice supporting the planning of the patient trajectory, 4) follow-up care services in general practice, and 5) improving the integration of care between general practice, municipality, and hospital. The pilot cluster RCT involve 350 patients with complicated multimorbidity across 14 general practices in Region Zealand and The Capital Region of Denmark. Patients are randomly assigned to either the intervention group or the usual care group. The primary outcome measure is the patients experience of quality of care measured by the Patient Assessment Chronic Illness Care Questionnaire (PACIC). Secondary outcomes include the patient's health-related quality of life, measured by the EuroQol-5 Domain questionnaire (EQ-5D-5L) and the treatment burden measured by the Multimorbidity Treatment Burden Questionnaire (MTBQ). Data on chronic conditions, healthcare utilization, and demographic information such as sex, age, and educational attainment will be collected from national registries. The outcome measures will be recorded before, during, and after implementing the intervention. Qualitative evaluation will include semi-structured interviews with healthcare professionals across various sectors as well as patients. The cost-effectiveness and Incremental Cost Effectiveness Ratio (ICER) of the CIM2 will be assessed using Diagnose Related Group rates. ClinicalTrials.gov Identifier: NCT05406193. https://clinicaltrials.gov/study/NCT05406193.

The DAWN antivirals trial: process evaluation of a COVID-19 trial in general practice.

The DAWN antivirals trial was a multicentric, randomised placebo-controlled trial evaluating antiviral medication for COVID-19 in general practice. The trial was prematurely terminated because of insufficient recruitment. To explore which factors contributed to the premature termination. General practice in Belgium. Patients were randomised to camostat or placebo (patients and physicians blinded) between June 2021 and July 2022; a third arm evaluating molnupiravir (open label) was opened in March 2022. The outcome assessor was blinded for all comparisons except for the patient reported outcomes in case of molnupiravir. The authors analysed available trial data and evaluated trial context, implementation, and mechanisms of impact based on semi-structured interviews with trial stakeholders. The trial recruited 44 participants; 19 were allocated to camostat (median age 55 years), 8 to molnupiravir (median age 60 years), and 17 to placebo (median age 56 years). There were no serious adverse events in either group. Most difficulties were related to the pandemic context: disruption to routine clinical services; multiple changes to the service model for COVID-19 patients; overwhelmed clinical staff; delays of trial medication; and staff shortages in the sponsor and clinical team. In addition, regulatory approval processes were lengthy and led to additional study procedures. It was felt that the trial started too late, when vaccinations had already begun. The DAWN antivirals trial was stopped prematurely. Although many barriers were related to the pandemic itself, hurdles such as a small and inexperienced sponsor and clinical teams, delays in regulatory processes, and research capacity in routine settings could be overcome by established research infrastructure and standardisation of processes.

Challenges in reaching patients with severe mental illness for trials in general practice—a convergent mixed methods study based on the SOFIA pilot trial

BackgroundPatients with severe mental illness (SMI) die prematurely due to undetected and inadequate treatment of somatic illnesses. The SOFIA pilot study was initiated to mend this gap in health inequity. However, reaching patients with SMI for intervention research has previously proven difficult. This study aimed to investigate the recruitment of patients with SMI for the SOFIA pilot study in 2021.MethodsWe used a mixed-method convergent design. The qualitative material comprised 20 interviews with general practitioners (GPs) and staff, during patient recruitment. The quantitative data consisted of process data on baseline characteristics, GPs reported reasons for excluding a patient, reported reasons for patients declining participation, and registered data from a Danish population of patients with SMI. We used thematic analysis in the qualitative analysis and descriptive statistics for the quantitative analysis. Pillar integration was used for integrating the material.ResultsOur findings show that selection bias occurred in the pilot study. We describe four main themes based on the integrated analysis that highlights selection issues: (1) poor data quality and inconsistency in defining severity definitions troubled identification and verification, (2) protecting the patient and maintaining practice efficiency, (3) being familiar with the patient was important for a successful recruitment, and (4) in hindsight, the GPs questioned whether the target population was reached. ConclusionsIn the light of theories of professions and street-level bureaucracy, we find that the main drivers of the patient selection bias occurring in the SOFIA pilot study were that 1) GPs and staff mended eligibility criteria to protect certain patients and/or to minimize workload and maintain efficiency in the practice 2) the data from the GP record systems and the digital assessment tool to assist recruitment was not optimal. Interventions targeting this patient group should carefully consider the recruitment strategy with a particular focus on professionals’ discretionary practices and information technology pitfalls.Trial registrationThe pilot trial protocol was registered on the 5th of November 2020. The registration number is NCT04618250.

Implementation and evaluation of a complex intervention to improve information availability at the interface between inpatient and outpatient care in older patients with multimorbidity and polypharmacy (HYPERION-TransCare) — study protocol for a pilot and feasibility cluster-randomized controlled trial in general practice in Germany

BackgroundDespite attempts to improve the cross-sectoral flow of information, difficulties remain in routine healthcare. The resulting negative impact on continuity of care is often associated with poor health outcomes, especially in older patients. Our intervention aims to increase information availability with respect to medications and health conditions at the interface between inpatient and outpatient care and to contribute towards improving the quality of care in older patients. This pilot study focuses on feasibility and implementability.MethodsThe idea of the complex intervention has been developed in a previous study. This intervention will be tested in a prospective, multicenter, cluster-randomized (via web tool), controlled pilot trial with two parallel study arms (intervention and control group). The pilot study will be conducted in 20 general practices in Hesse and Saxony (Germany) and include 200 patients (≥ 65 years of age with multimorbidity and polypharmacy) recruited by the practices. Practice staff and patients will be blinded. We will use qualitative and quantitative methods to assess the feasibility and implementability of the intervention and the study design in a process evaluation covering topics ranging from expectations to experiences. In addition, the feasibility of proposed outcome parameters for the future definitive trial will be explored. The composite endpoint will include health-related patient outcomes (hospitalization, falls, and mortality using, e.g., the FIMA questionnaire), and we will assess information on medications (SIMS questionnaire), symptoms and side effects of the medication (pro-CTCAE questionnaire), and health literacy (HLQ questionnaire).Data will be collected at study begin (baseline) and after 6 months. Furthermore, the study will include surveys and interviews with patients, general practitioners, and healthcare assistants.DiscussionThe intervention was developed using a participatory approach involving stakeholders and patients. It aims to empower general practice teams as they provide patient-centered care and play a key role in the coordination and continuity of care. We aim to encourage patients to adopt an active role in their health care. Overall, we want to increase the availability of health-related information for patients and healthcare providers. The results of the pilot study will be used in the design and implementation of the future definitive trial.Trial registrationThe study was registered in DRKS-German Clinical Trials Register: registration number DRKS00027649 (date: 19 January 2022).Date and version identifier10.07.2023; Version 1.3

The early use of Antibiotics for At-risk children with InfluEnza in Primary Care (the ARCHIE programme)

The early use of Antibiotics for At-risk children with InfluEnza in Primary Care (the ARCHIE programme)

Improving rural and regional access to long-acting reversible contraception and medical abortion through nurse-led models of care, task-sharing and telehealth (ORIENT): a protocol for a stepped-wedge pragmatic cluster-randomised controlled trial in Australian general practice

IntroductionWomen living in rural and regional Australia often experience difficulties in accessing long-acting reversible contraception (LARC) and medical abortion services. Nurse-led models of care can improve access to these services...

In it for the long haul: the complexities of managing overweight in family practice: qualitative thematic analysis from the Health eLiteracy for Prevention in General Practice (HeLP-GP) trial

BackgroundAustralia has one of the highest rates of overweight and obesity in the developed world, and this increasing prevalence and associated chronic disease morbidity reinforces the importance of understanding the attitudes, views, and experiences of patients and health providers towards weight management interventions and programs. The purpose of this study was to investigate patients, family practitioners and family practice nurses’ perceptions and views regarding the receipt or delivery of weight management within the context of the HeLP-GP intervention.MethodsA nested qualitative study design including semi-structured interviews with family practitioners (n = 8), family practice nurses (n = 4), and patients (n = 25) attending family practices in New South Wales (n = 2) and South Australia (n = 2). The patient interviews sought specific feedback about each aspect of the intervention and the provider interviews sought to elicit their understanding and opinions of the strategies underpinning the intervention as well as general perceptions about providing weight management to their patients. Interviews were recorded and transcribed verbatim, and coding and management conducted using NVivo 12 Pro. We analysed the interview data using thematic analysis.ResultsOur study identified three key themes: long-term trusting and supportive relationships (being ‘in it for the long haul’); initiating conversations and understanding motivations; and ensuring access to multi-modal weight management options that acknowledge differing levels of health literacy. The three themes infer that weight management in family practice with patients who are overweight or obese is challenged by the complexity of the task and the perceived motivation of patients. It needs to be facilitated by positive open communication and programs tailored to patient needs, preferences, and health literacy to be successful.ConclusionsProviding positive weight management in family practice requires ongoing commitment and an open and trusting therapeutic relationship between providers and patients. Behaviour change can be achieved through timely and considered interactions that target individual preferences, are tailored to health literacy, and are consistent and positive in their messaging. Ongoing support of family practices is required through funding and policy changes and additional avenues for referral and adjunctive interventions are required to provide comprehensive weight management within this setting.

Type 2 diabetes remission in Australian primary care: Protocol for an implementation study of the DiRECT-Aus trial

Type 2 diabetes is one of the most common chronic conditions managed in Australian general practice. DiRECT-Aus is replicating the UK Diabetes Remission Clinical Trial (DiRECT) in general practices across NSW. The aim of thestudy will be to explore the implementation of DiRECT-Aus to informfuture scale-up and sustainability. This is a cross-sectional qualitative study using semi-structured interviews to explore the experiences of patients, clinicians and stakeholders in the DiRECT-Aus trial. The Consolidated Framework for Implementation Research (CFIR) will be used to guide the exploration of the implementation factors, and the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework to report on implementation outcomes. Interviews will be conducted with patients and key stakeholders. Initial coding will be based on the CFIR, with inductive coding used to develop the themes. This implementation study will identify factors to be considered and addressed so that future scale-up and national delivery will be equitable and sustainable.

Digital redesign of hypertension management with practice and patient apps for blood pressure control (PIA study): A cluster-randomised controlled trial in general practices.

Long-term hypertension control prevents heart attacks and other cardiovascular diseases, yet implementation is insufficient worldwide. The redesign of hypertension management by information and communication technology (ICT) improved hypertension control, e.g., by transmission of blood pressure (BP) measurements to a central webspace. However, an easy-to-use secure patient app connected with a practice management centre is lacking. This study evaluates the effectiveness of the newly developed PIA (PC-supported case management of hypertensive patients to implement guideline-based hypertension therapy using a physician-defined and -supervised, patient-specific therapeutic algorithm) intervention with PIA-ICT and eLearning for general practices. The effectiveness of the PIA intervention was evaluated in a cluster-randomised study. Practices were randomly allocated (1:1) to the intervention or the control group (usual care). Group allocation was unmasked for participants and researchers. The primary outcome was the BP control rate (BP<140/90mmHg) after 6-12months. Secondary outcomes included BP changes and satisfaction with PIA-ICT. The trial is registered in the German Clinical Trials Register (DRKS00012680). Starting from December 1, 2019, 64 general practices were recruited over 1 year during the COVID-19 pandemic. Overall, 848 patients were enrolled between April 15, 2020 and March 31, 2021. The study was completed Sept 30, 2021. At baseline, 636 patients (intervention: 331; control: 305) of 50 general practices met the inclusion criteria. The final dataset for analyses comprised 47 practices and 525 patients (intervention 265; control 260). In the adjusted hierarchical model, the PIA intervention increased the BP control rate significantly by 23.1% points (95% CI: 5.4-40.8%): intervention 59.8% (95% CI: 47.4-71.0%) compared to 36.7% (95% CI: 24.9-50.3%) in the control group. Systolic BP decreased by 21.1mmHg in the intervention and 15.5mmHg in the control group. The PIA redesign of care processes improved BP in an outcome-relevant way. Prospectively, it may constitute an important model for hypertension care in Germany. This study is funded by the German Innovation Fund (Grant number: 01NVF17002).

Sustainable and effective methods to increase long‐acting reversible contraception uptake from the ACCORd general practice trial

ObjectiveMost Australian women access contraception through general practitioners (GPs) but choose oral methods rather than long‐acting reversible contraceptives (LARCS). The Australian Contraceptive ChOice pRoject (ACCORd) successfully tested a complex intervention for LARC uptake. We aimed to explore the critical elements of this intervention to increase LARC uptake. DesignACCORd was a cluster randomised control trial conducted in 57 GP clinics in Melbourne, Australia. To explore intervention impact, fidelity checks (n=21 GPs) and interviews with 37 GPs and 40 patients were undertaken 12 months after initial consultations. Data were inductively coded, thematically analysed and mapped to Normalization Process Theory constructs. ResultsDoctors understood the importance of effectiveness‐based contraceptive counselling (EBCC). GPs demonstrated cognitive engagement in the promotion of LARC and some appreciated the rapid referral pathways. GPs and women valued the effectiveness approach. GPs held varying views about having a rapid referral pathway, with many already having established pathways in place. Some GPs viewed intrauterine device insertion costs or insertion training as barriers to ongoing practice. Most GPs and women saw the ACCORD model as effective and sustainable. ConclusionsGP training in EBCC and the use of rapid referral pathways were critical features of an effective sustainable model for successful uptake of LARCs in primary care. Implications for public healthImproving Australian women's access to and use of LARCs is sustainable with EBCC training and support for general practitioners.

Comparison of Motivational Short Interventions to Improve Smokers' Health Behavior (The COSMOS Study): A Pragmatic Cluster-Randomized Two-Arm Trial in General Practice.

Helping smokers to quit is an important task of general practitioners (GPs). However, achieving tobacco abstinence is difficult, and smokers who fail may still want to improve their health in other ways. Therefore, Swiss GPs developed a multithematic coaching concept that encourages health behavior changes beyond smoking cessation alone. To compare the effectiveness of such coaching with state-of-the-art smoking cessation counseling, we conducted a pragmatic cluster-randomized two-arm trial with 56 GPs in German-speaking Switzerland and 149 of their cigarette smoking patients. GPs were instructed in either multithematic health coaching or smoking cessation counseling. After 12 months, we compared their patients' improvements in cigarette consumption, body weight, physical inactivity, alcohol consumption, stress, unhealthy diet, and a health behavior of their own choice, using hierarchical logistic regression models and Fisher's exact and t tests. Over 95% of all participants achieved clinically relevant improvements in at least one health behavior, with no difference between study arms (health coaching vs. smoking cessation counseling: aOR = 1.21, 95% CI = [0.03-50.76]; and aOR = 1.78, 95% CI = [0.51-6.25] after non-responder imputation). Rates of clinically relevant improvements in the individual health behaviors did not differ between study arms either (they were most frequent in physical activity, achieved by 3 out of 4 patients), nor did the extent of the improvements. Multithematic health coaching and state-of-the art smoking cessation counseling were found to be comparable interventions, both in terms of smoking cessation success and, quite unexpectedly, their effects on other health behaviors. The findings of our study suggest that in general practice, multithematic health coaching is an effective smoking cessation intervention, and conversely, monothematic smoking cessation counseling also achieves the beneficial effects of a multithematic health behavior intervention. This opens up the possibility for GPs to support their smoking patients in improving their health behavior in additional and more flexible ways.

Designing a decision aid for cancer prevention.

10531 Background: Australian guidelines recommend those aged 50 to 70-years-old without contraindications, consider taking low-dose aspirin (100 mg – 300 mg per day) for at least 2.5 years to reduce their risk of colorectal cancer. To increase uptake of the new guidelines, we hypothesized that a decision aid (DA) would help facilitate a discussion between clinicians and patients about aspirin chemoprevention. We aimed to design a DA with clinician and consumer input including state-of-the-art expected frequency trees (EFTs). We aimed to explore clinicians’ opinions about using EFTs with their patients during consultations and gain consumers feedback on DAs including their understanding and their hypothetical decision to take aspirin or not. Methods: Semi-structured interviews were conducted with relevant clinicians including familial cancer clinic staff (geneticists, oncologists and genetic counsellors), gastroenterologists, pharmacists, and general practitioners (GPs). Focus groups were conducted with consumers in the target age range of the guidelines. DAs were developed through an iterative process. The clinician and focus group interview schedules covered ease of comprehension, design, potential effects on decision making, and approaches to implementation of the DA. Coding was inductive and the focus group interviews were independently coded by two researchers. Themes were developed through consensus between the authors. Final versions of the DAs were proposed to consumers for their final approval after all changes were made. Results: Sixty-four interviews were completed with clinicians between March and October 2019. Twelve consumers, aged 50 to 70 years, participated in two focus groups in February and March 2020. The clinicians agreed that the EFTs would be helpful to facilitate a discussion with patients but suggested including an additional estimate of the effects of aspirin on all-cause mortality. Clinicians agreed that patients would benefit from being shown the EFT in a consultation. The consumers felt favorable about the DA, especially if used with a clinician, and suggested some additional changes to the design and wording to improve ease of comprehension. Conclusions: We have designed a DA using novel approaches to communicate risks and benefits of low dose aspirin for cancer and cardiovascular disease prevention. The DAs are currently being trialled in the SITA trial in general practice to determine its impact on informed decision-making and aspirin uptake.

Nationwide implementation of online communication skills training to reduce overprescribing of antibiotics: a stepped-wedge cluster randomized trial in general practice.

ObjectivesPrimary care is responsible for a large proportion of unnecessary antibiotic use, which is one of the main drivers of antibiotic resistance. Randomized trials have found that online communication skills training for GPs reduces antibiotic prescribing for respiratory infections. This study assesses the real-world effect of implementing online communication skills training in general practice.MethodsIn a closed cohort stepped-wedge cluster randomized trial all Belgian GPs were invited to participate in online communication skills training courses (TRACE and INTRO) and provided with linked patient information booklets. The primary outcome was the antibiotic prescribing rate per 1000 patient contacts. Intention-to-treat and per protocol analyses were performed. Trial registration at ClinicalTrials.gov: NCT03265028.ResultsIn total, 118 487 observations from 10 375 GPs were included in the analysis. Overall, 299 (2.88%) GPs completed TRACE and 93 (0.90%) completed INTRO, 30 of which completed both. There was no effect of the national implementation of TRACE and INTRO on the population-level antibiotic prescribing rate (prescribing rate ratio [PRR] = 0.99 [95% CI: 0.97–1.02]). GPs who actually completed TRACE prescribed fewer antibiotic prescriptions (PRR = 0.93 [95% CI: 0.90–0.95]).ConclusionsInviting GPs to complete an online communication skills training course and providing them with the linked patient information booklets did not reduce antibiotic prescribing. However, GPs who completed TRACE prescribed 7% fewer antibiotics, especially during winter. This suggests a significant decrease in population-wide antibiotic consumption could be achieved by focusing on increasing the uptake of this intervention by identifying and overcoming barriers to participation.

A general practice intervention for people at risk of poor health outcomes: the Flinders QUEST cluster randomised controlled trial and economic evaluation.

ObjectiveTo determine whether a multicomponent general practice intervention cost‐effectively improves health outcomes and reduces health service use for patients at high risk of poor health outcomes.Design, settingClustered randomised controlled trial in general practices in metropolitan Adelaide.ParticipantsThree age‐based groups of patients identified by their general practitioners as being at high risk of poor health outcomes: children and young people (under 18 years), adults (18–64 years) with two or more chronic diseases, and older people (65 years or more).InterventionEnrolment of patients with a preferred GP, longer general practice appointments, and general practice follow‐up within seven days of emergency department and hospital care episodes. Intervention practices received payment of $1000 per enrolled participant.Main outcome measuresPrimary outcome: change in self‐rated health between baseline and 12‐month follow‐up for control (usual care) and intervention groups. Secondary outcomes: numbers of emergency department presentations and hospital admissions, Medicare specialist claims and Pharmaceutical Benefits Scheme (PBS) items supplied, Health Literacy Questionnaire scores, and cost‐effectiveness of the intervention (based on the number of quality‐adjusted life‐years [QALYs] gained over 12 months, derived from EQ‐5D‐5L utility scores for the two adult groups).ResultsTwenty practices with a total of 92 GPs were recruited, and 1044 eligible patients participated. The intervention did not improve self‐rated health (coefficient, –0.29; 95% CI, –2.32 to 1.73), nor did it have significant effects on the numbers of emergency department presentations (incidence rate ratio [IRR], 0.90; 95% CI, 0.69–1.17), hospital admissions (IRR, 0.90; 95% CI, 0.66–1.22), Medicare specialist claims (IRR, 1.00; 95% CI, 0.91–1.09), or PBS items supplied (IRR, 0.99; 95% CI, 0.96–1.03), nor on Health Literacy Questionnaire scores. The intervention was effective in terms of QALYs gained (v usual care: difference, 0.032 QALYs; 95% CI, 0.001–0.063), but the incremental cost‐effectiveness ratio was $69 585 (95% CI, $22 968–$116 201) per QALY gained, beyond the willingness‐to‐pay threshold.ConclusionsOur multicomponent intervention did not improve self‐rated health, health service use, or health literacy. It achieved greater improvement in quality of life than usual care, but not cost‐effectively.Trial registrationAustralian New Zealand Clinical Trials Registry, ACTRN12617001589370 (prospective).

Cost-effectiveness analysis of acupuncture compared with usual care for acute non-specific low back pain: secondary analysis of a randomised controlled trial.

Objective:To assess the cost-effectiveness of a single treatment session of acupuncture, when applied in addition to usual care for acute low back pain (ALBP).Methods:Secondary analysis of a multicentre randomised controlled trial in Norwegian general practice. In total, 171 participants with ALBP ⩽14 days were randomised to a control group (CG) receiving usual care or to an acupuncture group (AG) receiving one additional session of Western medical acupuncture alongside usual care. Primary outcome measures for this cost-effectiveness analysis were quality-adjusted life years (QALYs), health care costs and societal costs at days 28 and 365, the incremental cost-effectiveness ratio (ICER) and net monetary benefit (NMB). The NMB was calculated on the basis of the Norwegian cost-effectiveness threshold of NOK 275,000 (USD 35,628) per QALY gained. Missing data were replaced by multiple chained imputation.Results:Eighty-six participants in the CG and 81 in the AG were included in the analysis. We found no QALY gain at day 28. At day 365, the incremental QALY of 0.035 was statistically significant. The differences in health care costs and societal costs were not statistically significant. Three out of four calculations led to negative ICERs (cost saving) and positive NMBs. For the health care perspective at day 365, the ICER was USD –568 per QALY and the NMB was USD 1265, with 95.9% probability of acupuncture being cost-effective.Conclusion:To our knowledge, this is the first cost-effectiveness analysis of acupuncture for ALBP. The findings indicate that acupuncture may be cost-effective from a 1-year perspective, but more studies are needed.Trial registration number:NCT01439412 (ClinicalTrials.gov).

Urine collection devices to reduce contamination in urine samples for diagnosis of uncomplicated UTI: a single-blind randomised controlled trial in primary care

BackgroundUrine collection devices (UCDs) are being marketed and used in clinical settings to reduce urine sample contamination, despite inadequate supporting evidence.AimTo determine whether UCDs, compared with standardised instructions for urine sample collection, reduce the proportion of contaminated samples.Design and settingSingle-blind randomised controlled trial in general practices in England and Wales.MethodWomen aged ≥18 years presenting with symptoms attributable to urinary tract infection (UTI) were randomised (1:1:1) to use either a Peezy UCD or a Whiz Midstream UCD, or were given standardised verbal instructions (SVI) for midstream sample collection. The primary outcome was the proportion of urine samples reported as contaminated by microbiology laboratory analysis.ResultsA total of 1264 women (Peezy UCD: n = 424; Whiz Midstream UCD: n = 421; SVI: n = 419) were randomised between October 2016 and August 2018. Ninety women were excluded from the primary analysis as a result of ineligibility or lack of primary outcome data, leaving 1174 (Peezy UCD: n = 381; Whiz Midstream UCD: n = 390; SVI: n = 403) for intention-to-treat analysis. The proportion of contaminated samples was 26.5% with the Peezy UCD, 28.2% with the Whiz Midstream UCD, and 29.0% with SVI (relative risk: Peezy UCD versus SVI = 0.91, 95% CI = 0.76 to 1.09, P = 0.32; Whiz Midstream UCD versus SVI = 0.98, 95% CI = 0.97 to 1.20, P = 0.82). There were 100 (25.3%) device failures with the Peezy UCD and 35 (8.8%) with the Whiz Midstream UCD; the proportion of contaminated samples was similar after device failure samples were excluded.ConclusionNeither the Peezy UCD nor the Whiz Midstream UCD reduced urine sample contamination when used by women presenting to primary care with suspected UTI. Their use cannot be recommended for this purpose in this setting.

Safer Prescribing and Care for the Elderly (SPACE): a cluster randomised controlled trial in general practice.

BackgroundSafer prescribing in general practice may help to decrease preventable adverse drug events (ADE) and related hospitalisations.AimTo test the effect of the Safer Prescribing and Care for the Elderly (SPACE) intervention on high-risk prescribing of non-steroidal anti-inflammatory drugs (NSAIDs) and/or antiplatelet medicines and related hospitalisations.Design & settingA pragmatic cluster randomised controlled trial in general practice. Participants were patients at increased risk of ADEs from NSAIDs and/or antiplatelet medicines at baseline. SPACE comprises automated search to generate for each GP a list of patients with high-risk prescribing; pharmacist outreach to provide education and one-on-one review of list with GP; and automated letter inviting patients to seek medication review with their GP.MethodThe primary outcome was the difference in high-risk prescribing of NSAIDs and/or antiplatelet medicines at 6 months. Secondary outcomes were high-risk prescribing for gastrointestinal, renal, or cardiac ADEs separately, 12-month outcomes, and related ADE hospitalisations.ResultsThirty-nine practices were recruited with 205 GPs and 191 593 patients, of which 21 877 (11.4%) were participants. Of the participants, 1479 (6.8%) had high-risk prescribing. High-risk prescribing improved in both groups at 6 and 12 months compared with baseline. At 6 months, there was no significant difference between groups (odds ratio [OR] 0.99; 95% confidence intervals [CI] = 0.87 to 1.13) although SPACE improved more for gastrointestinal ADEs (OR 0.81; 95% CI = 0.68 to 0.96). At 12 months, the control group improved more (OR 1.29; 95% CI = 1.11 to 1.49). There was no significant difference for related hospitalisations.ConclusionFurther work is needed to identify scalable interventions that support safer prescribing in general practice. The use of automated search and feedback plus letter to patient warrants further exploration.